Description and Brand Names

US Brand Name

Mekinist

Descriptions

Trametinib is used alone or in combination with dabrafenib to treat melanoma (skin cancer) that has spread or that cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E or V600K mutations. Your doctor will use a special test to look for these mutations. Trametinib belongs to the group of medicines called antineoplastics (cancer medicines).

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of trametinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of trametinib in the elderly.

Pregnancy

Information about this trametinib-oral-route

Pregnancy Category

Explanation

All Trimesters

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Eye or vision problems or

Heart disease (eg, cardiomyopathy) or

Hypertension (high blood pressure) or

Lung disease or other breathing problems—Use with caution. May make these conditions worse.

Proper Use

Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine at least 1 hour before or 2 hours after a meal.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For melanoma:

Adults—2 milligrams (mg) once a day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original bottle. Protect from moisture and light.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 4 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause fertility (ability to have children) problems in women. Talk to your doctor before using this medicine if you plan to have children.

This medicine may cause heart problems, including heart failure. Check with your doctor right away if you have chest pain, decreased urine output, an uneven heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or rapid weight gain while using this medicine.

Check with your doctor right away if blurred vision, loss of vision, or any change in vision occurs during treatment. These could be symptoms of a serious eye problem. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Tell your doctor right away if you have a cough, shortness of breath, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have a severe skin rash, acne, or redness, swelling, peeling, or tenderness of the hands or feet. These may be symptoms of a serious skin problem.

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. Symptoms of high blood pressure are blurred vision, severe headache, a slow or fast heartbeat, lightheadedness, or dizziness.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding from the rectum or bloody stools

bleeding gums

blemishes on the skin

blistering, crusting, irritation, itching, or reddening of the skin

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody nose

blurred vision

chest discomfort or pain

cracked, dry, or scaly skin

decreased urine output

diarrhea

dilated neck veins

dizziness

extreme fatigue

faintness

fast, slow, irregular, or pounding heartbeat

headache

irregular breathing

irregular heartbeat

lightheadedness, dizziness, or fainting

nervousness

pimples

pounding in the ears

rapid weight gain

rash

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

shortness of breath

tightness in the chest

tingling of the hands and feet

troubled breathing

ulceration of the skin

unusual tiredness or weakness

unusual weight gain or loss

Less common

Cough

fever

Rare

Change in vision

seeing flashes or sparks of light

seeing floating spots before the eyes, or a veil or curtain across part of your vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach pain

burning, itching, and pain in hairy areas, pus at the root of the hair

canker sores

change in taste

dark-colored urine

dry eyes

dry mouth

dry skin

itching, pain, redness, swelling, tenderness, or warmth on the skin

loosening of the fingernails

loss of taste

muscle cramps or spasms

muscle pain or stiffness

redness or soreness around the fingernails

sores, ulcers, or white spots on the lips or tongue or inside the mouth

swelling or inflammation of the mouth

thirst

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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